Did FDA Report Find All-Cause Mortality Higher Among Vaccinated?

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In Brief

  • The Facts:
    • The FDA released data from the Pfizer COVID vaccine trials they used to help authroize the vaccine for use.

    • The data appears to show a 24% increase in all-cause mortality among the vaccinated vs unvaccinated.

    • But because Pfizer vaccinated most in the placebo group, this statistic no longer has significance.

    • It's important now more than ever to take signals from vaccine reporting systems.

  • Reflect On:
    • Have we done a comprehensive risk benefit analysis of vaccine related adverse events, including death, compared to the actual risk of COVID?

    • Since the vaccine does not stop transmission or infection, and wanes over time, does it make sense to mandate this vaccine when we don't know the side effects yet a signal exists saying there are some?

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The intention of this piece is to explore a misunderstanding forming around new FDA report regarding Pfizer’s COVID vaccine trials and all cause mortality. The claim is that the rate of all cause mortality is significantly higher in the vaccinated group, yet the trial doesn’t illustrate this.

That said, we must understand that Pfizer’s trial was not powerful enough to pick up on widescale issues as it was small and short. Further, we are still seeing strong signals of vaccine injury in the real world data, and we cannot look to Pfizer’s trial to understand it.

The FDA Report

A new FDA report appears to show Pfizer’s COVID vaccine clinical trials saw a 24% higher all-cause mortality rate among the vaccinated compared to the placebo group. According to the report, “None of the deaths were considered related to vaccination.”

The data shows that the total number of deaths is 17 in the placebo group and 21 in the vaccine group, a difference of about 23.5%.

“From Dose 1 through the March 13, 2021 data cutoff date, there were a total of 38 deaths, 21 in the COMIRNATY group and 17 in the placebo group. None of the deaths were considered related to vaccination.”

November 8, 2021 Summary Basis for Regulatory Action – Comirnaty

But by July 2020, Pfizer offered everyone in the placebo group the vaccine. According to Pfizer, most of the participants accepted vaccination.

After this two things happened:

1. It effectively killed any chance of seeing long term issues with vaccination as the trial was now over.

2. It changed the number of people in each arm of the trial. The vaccinated group would now be much larger in total people because many in the placebo arm became vaccinated. We can no longer make like comparisons.

Because the FDAs report includes surveillance up to March, 2021, there were no longer the same number of people in the vaccine group and the placebo group, effectively negating the significane of the all-cause mortality statistic people were referencing.

But since Pfizer ended the trials so quickly, we now have no choice but to look at numbers in reporting systems like VAERS, of the UK’s Yellow Card system.

Making Sense of Adverse Vaccine Events

Perhaps the reason why many people wanted to lean on the FDA data showing all cause mortality as being higher in the vaccinated group is because vaccine reporting systems are signalling something that requires further investigation.

We’re seeing an unexpetedly high rate of death and severe injury from COVID vaccines. Not to mention that many observations made by doctors within their case loads are indicating more injury than expected.

From a completely anecdotal perspective, I have spoken to many healtcare providers over the last 8 months who have stated they have many patients coming in who have been vaccinated and their pre-existing conditions, like heart disease, have intensified following vaccination. Of course we can’t prove a causal link right away, but it’s a signal needing to be followed up on.

If these observations turn out to be a larger issue, vaccinations may be causing long term damage that will be hard to track months out from vaccination. Assuming that we’re going to see a causal link very early on is, frankly, silly.

It typically takes years to determine causal links between pharmaceutical products and unintended consequences. This is why trials are often so long. This is also why it’s lazy to simply brush off what injury reports are saying, espcially given that the VAERS system and the UK yellow Card system are actually showing similar rates of injury – i.e. they are corroborating each other.

For example, right now the VAERS system is showing the risk of death from vaccination is about 1 in 23,000, just outside what the Pfizer trials would have capture if the trials were larger. The UK’s system shows deaths at about 1 in 26,641. These numbers are eerily close and something we should pay attention to because we’re now able to make sense of whether certain age groups are actually at a greater risk of death from the vaccine than they are from COVID.

If it happens to be true that vaccine injuries are also being under reported, we might be missing a public health crisis not based on a lack of evidence and curiosity but based on being stuck in an ideological war.

Here at The Pulse, we have tried to bring forth the idea, that many doctors are simply not acknowledging vaccine injuries, and thus we really have no idea the rate at which they are happening.

This would be a less important conversation if COVID was a very dangerous and deadly disease, but the data simply doesn’t support the idea of turning away from questoining whether restrictions and interventions might be doing more harm than the disease itself.

study from July 2021 by John P.A. Ioannidis concluded that your chances of dying from COVID if you are infected with it, in the following age groups is:

0-19 = 0.0027%
20-29 = 0.014%
30-39 = 0.031%
40-49 = 0.082%
50-59 = 0.27%
60-69 = 0.59%
70+ = 2.4%

So no, the Pfizer data doesn’t show a 24% higher all-cause mortality rate among the vaccinated compared to the placebo group, that is not the full picture. The truth is that the entire trial was made void when those in the placebo group were vaccinated.

If this piece helps us unite in any way, ideally is inspires us all to take a moment to step back, beyond the fear, beyond the voices of the ‘authority’ and ask: what is really happening here?

Are we able to humble ourselves so we can stand side by side, not against each other, and make sense of what is going on?

We must set aside terms like ‘anti-vaxxer’ and “sheeple” and simply look at what the story and what the data tells us. This is a moment calling for emotional regulation, a look at our bias’ and an engagement in asking questions that can lead us in a direction of unity as opposed to war.

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